Methods |
Randomized, placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: not reported. |
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Setting: Central Baptist Hospital, Lexington, Kentucky, US. |
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Inclusion criteria: women undergoing primary, non-elective CS (while it appears most women were in labor and/or had ruptured membranes it is unclear whether all patients fulfilled our criteria for non-elective) |
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Exclusion: antibiotic use within 7 days, penicillin or cephalosporin allergy |
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Interventions |
Cefamandole 500 mg IV immediately after the cord was clamped, again in the recovery room and two more doses 6 hours apart (N = 43) vs identical-appearing placebo (N = 47) |
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Outcomes |
Infectious morbidity (fever > 100.3°F twice 6 hours apart after first 24 hours); endomy-ometritis (fever, uterine tenderness, and positive culture from endometrium); wound infection, UTI; maternal duration of stay (treatment 5.1 days vs placebo 5.4; not significant, no variance given) |
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Notes |
There was 1 episode of bacteremia in the control group. |
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Class of antibiotic: second generation cephalosporin. |
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Subgroups: |
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type CS unclear;
after cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
Randomized. No further information. |
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Allocation concealment? |
Yes |
“according to pre-numbered envelopes maintained in the central pharmacy.” |
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Blinding? |
Yes |
Described as “double-blind”. |
All outcomes |
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Placebo-controlled: “identical appearing, equal volume solution” |
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Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
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No participant excluded. |
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ITT analysis. |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, race, parity, weight, type of anesthesia, operating time or pre-operative hematocrit. There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |